Brain Neoplasms
Conditions
Keywords
Brain metastases, neurosurgery, intraoperative radiotherapy, local therapy
Brief summary
To evaluate the feasibility and efficacy of the Intraoperative Radiation Therapy (IORT) after the resection of a brain metastases to reduce the incidence of local relapse
Interventions
RADIATIONIntraoperative Radiotherapy (IORT)
If biopsy is positive, local treatment with IORT will be performed. After IORT (15,40 Gray at 2 mm dept), the applicator will be removed and surgery will be continued in a standard fashion.
PROCEDUREBrain surgery
Surgery should be performed according to the local standard of care, preferentially as image-(neuronavigation) guided surgery. To establish the diagnosis of a metastasis and to exclude primary CNS tumors, lymphomas, SCLCs or germinomas it will be performed a peroperative biopsy
Sponsors
Institut Català d'Oncologia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Intraoperative Radiation Therapy (IORT)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥ 18 years, Karnofsky Performance Index ≥ 70. * Newly diagnosed cerebral or cerebellar lesion (contrast enhancing on a T1- weighted MRI scan) amenable to total resection with no dural attachment. * Frozen section confirming a metastasis of an extracranial (i.e. non-CNS) tumor. * Adequate distance to optic nerve(s), chiasm and brainstem (organs at risk for radiotherapy). * Adequate birth control. * Informed consent.
Exclusion criteria
* Leptomeningeal spread and dural attachment (assessed pre- and intraoperative). * Frozen section reveals primary CNS tumor, lymphoma, SCLC or germinoma. * Psychiatric or social condition potentially interfering with compliance. * Contraindication against anesthesia, surgery, MRI and/or contrast agents. * Pregnant or breast-feeding women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median local progression free survival (PFS) | 12 months | Time span (in months) between surgery and recurrence within a 0,5 cm margin around the resection cavity, evaluated through Response Assessment in Neuro-Oncology (RANO) criteria for brain metastasis obtained from serial Magnetic resonance imaging (MRI) scans. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global PFS (gPFS) | 12 months | Time (in months) from surgery to any intra- and extracranial tumor progression evaluated through Response Assessment in Neuro-Oncology (RANO) criteria for brain metastasis obtained from serial Magnetic resonance imaging (MRI) scans. |
| Median time to the initiation of systemic therapies | 12 months | Time (in days) from surgery to the day of initiation of any systemic anti-tumor therapy (e.g., chemotherapy) |
| Median overall survival (OS) | 12 months | Time (in months) from surgery of brain metastases to death by any cause |
| Change in neurocognitive performance (compared to baseline): Minimental | 6, and 12 months | Assessed by minimal mental scale examination |
| Change in neurocognitive performance (compared to baseline): Trail making | 6, and 12 months | Assessed by trail making test |
| Median regional PFS (rPFS) | 12 months | The time (in months) from surgery to any progression outside of the 0,5 cm margin around the resection cavity, evaluated through Response Assessment in Neuro-Oncology (RANO) criteria for brain metastasis obtained from serial Magnetic resonance imaging (MRI) scans. |
| Change in neurocognitive performance (compared to baseline): Oral | 6, and 12 months | Assessed by controlled oral word association test |
| Change in neurocognitive performance (compared to baseline): Semantic | 6, and 12 months | Assessed by semantic word association |
| Quality of life (QoL) | 6, and 12 months | Assessed by European Organization for Research and Treatment (EORTC)- Quality of Life Questionnaires (QLQ C30/BN20) |
| Radiation-related (acute / early delayed / late) neurotoxicity | 12 months | Assessed by regular neurological examinations combined by serial MRI scans |
| Change in neurocognitive performance (compared to baseline): Repetition | 6, and 12 months | Assessed by number repetition test (forward and backward) |
Countries
Spain
Contacts
Primary ContactMiquel Macià, MD
Outcome results
None listed